Company
United StatesTrutek Corp, Somerville, NJ – FDA Inspections
Inspection records and compliance data for Trutek Corp in Somerville, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected January 16, 2026.
Company Profile
This profile covers Trutek Corp based in Somerville, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 18, 2024. Last inspected January 16, 2026.
Most cited issue areas
- Design control - no procedures2 inspections
- Label to bear a unique device identifier2 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1298746 |
| January 18, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1227244 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Trutek Corp
FEI Number
3008653514
Address
281 E Main St, Somerville, New Jersey 08876, United States
Country
United States
ID: cfd4cf33-8ea2-4189-adc8-f604fd8f311d